FORZEROL-100/200/400 Zorvicap

Formoterol fumarate dihydrate and Budesonide Powder for Inhalation I.P.
Patient Information Leaflet

FORZEROL Zorvicap

forzerol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

  1. What FORZEROL Zorvicap is and what it is used for
  2. What you need to know before you use FORZEROL Zorvicap
  3. How to use FORZEROL Zorvicap
  4. Possible side effects
  5. How to store FORZEROL Zorvicap
  6. Contents of the pack and other information

1. What FORZEROL Zorvicap is and what it is used for

FORZEROL Zorvicap contains two medicines:

  • Budesonide – an inhaled corticosteroid that reduces inflammation in the lungs
  • Formoterol fumarate dihydrate – a long-acting bronchodilator (LABA) that helps keep the airways open

FORZEROL Zorvicap is used in:

Asthma

It is used for the regular treatment of asthma where the use of a combination of an inhaled corticosteroid and a long-acting bronchodilator is appropriate.

Depending on your doctor’s advice, FORZEROL Zorvicap may be used:

  • As maintenance therapy (regular daily treatment), with a separate reliever inhaler if needed
    or
  • In selected patients, as maintenance and reliever therapy (for certain strengths only), both as regular treatment and as needed for symptom relief

Chronic Obstructive Pulmonary Disease (COPD)

It is also used for the regular treatment of patients with moderate to severe COPD who have frequent symptoms and a history of exacerbations.

2. What you need to know before you use FORZEROL Zorvicap

Do not use FORZEROL Zorvicap if:

  • You are allergic to budesonide, formoterol, or any of the other ingredients of this medicine

Warnings and precautions

Talk to your doctor before using FORZEROL Zorvicap if:

  • You have worsening asthma or sudden breathing difficulty
  • You have heart disease, irregular heartbeat, high blood pressure, or prolonged QT interval
  • You have diabetes
  • You have an overactive thyroid gland
  • You have low potassium levels
  • You have severe liver problems
  • You have tuberculosis or any lung infection
  • You have a fungal, viral, or bacterial infection of the airways
  • You are switching from oral steroids
  • You have a history of adrenal suppression

Important information about asthma

  • FORZEROL Zorvicap should not be used to start treatment during a sudden severe worsening of asthma or COPD
  • If your symptoms get worse or you need your reliever medicine more often, contact your doctor immediately
  • If wheezing gets worse immediately after inhalation (paradoxical bronchospasm), stop using it and seek medical advice at once

Important information about LABA medicines

  • Long-acting beta2 agonists (LABA) should not be used alone in asthma
  • In FORZEROL Zorvicap, formoterol is combined with budesonide (an inhaled corticosteroid), which is the appropriate combination for asthma treatment

Children and adolescents

  • Use in children should be only as prescribed by the doctor
  • Growth in children receiving prolonged inhaled corticosteroid treatment may need monitoring

Other medicines and FORZEROL Zorvicap

Tell your doctor if you are taking or have recently taken any other medicines, especially:

  • Ketoconazole, itraconazole, or other strong CYP3A4 inhibitors
  • Ritonavir, cobicistat-containing medicines
  • Beta-blockers
  • Diuretics
  • Xanthines
  • Steroids
  • Medicines that may affect heart rhythm
  • Other LABA-containing inhalers

Do not use additional LABA medicines while using FORZEROL Zorvicap, unless specifically advised by your doctor.

Pregnancy and breastfeeding

  • If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor before using this medicine
  • During pregnancy, FORZEROL Zorvicap should only be used if the benefits outweigh the risks
  • Budesonide passes into breast milk in small amounts; ask your doctor before use during breastfeeding

Driving and using machines

  • This medicine is not expected to affect your ability to drive or use machines
  • If you feel dizzy or unwell, do not drive or operate machinery

3. How to use FORZEROL Zorvicap

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Asthma

The dose is individual and depends on the severity of your asthma. Your doctor will prescribe the lowest dose that controls your symptoms.

FORZEROL Zorvicap may be used in two ways:

A. Maintenance Therapy
You take FORZEROL Zorvicap regularly every day and use a separate fast-acting reliever inhaler when needed.

B. Maintenance and Reliever Therapy
(For FORZEROL-100 and FORZEROL-200 only, if prescribed by your doctor)
You take FORZEROL Zorvicap regularly every day and also use FORZEROL Zorvicap as needed for symptom relief.

  • This approach is not recommended in children and adolescents
  • FORZEROL-400 Zorvicap should not be used for maintenance and reliever therapy

COPD

For COPD, FORZEROL Zorvicap is used as regular maintenance treatment as prescribed by your doctor.

Method of administration

FORZEROL Zorvicap is for oral inhalation only (Dry Powder Inhalation through a capsule-based DPI device).

Instructions for correct use of FORZEROL Zorvicap

Administration Information

  • FORZEROL Zorvicap should be used by inhalation through the prescribed Dry Powder Inhaler (DPI) device
  • The inhaler is inspiratory flow-driven, meaning the powder is carried into the airways when you inhale forcefully through the mouthpiece
  • After inhalation, rinse your mouth with water and spit it out to reduce the risk of oral thrush

Step-by-Step Instructions for FORZEROL Zorvicap Use

  1. Prepare: Wash and dry your hands. Take one FORZEROL Zorvicap from the bottle just before use. Ensure the inhaler device is clean and dry.
  2. Open the Device: Open the Dry Powder Inhaler (DPI) device as per its design.
  3. Load the Capsule: Place the FORZEROL Zorvicap only into the capsule chamber. Do not place the capsule in the mouthpiece.
  4. Close the Device: Close the device firmly until you hear or feel a click.
  5. Pierce the Capsule: Activate the piercing mechanism as per device design to pierce the capsule so the powder can be released during inhalation.
  6. Exhale Fully (Away from Device): Breathe out completely away from the mouthpiece. Do not exhale into the device.
  7. Inhale the Medicine: Seal your lips tightly around the mouthpiece. Inhale quickly, deeply, and forcefully through the mouth.
  8. Hold Breath: Remove the inhaler and hold your breath for 5–10 seconds, or as long as comfortable. Then breathe out slowly.
  9. Check the Capsule: Open the device and inspect the capsule. If powder remains, repeat inhalation using the same capsule until empty. Discard the empty capsule.
  10. After Use: Close the device. Rinse your mouth and gargle with water after use. Spit it out.

Important points

  • Do NOT swallow the FORZEROL Zorvicap
  • Do NOT chew, open, or break the capsule
  • One capsule = one inhaled dose
  • You may not taste or feel the medicine because only a small amount of powder is delivered each time
  • More frequent use or higher doses than prescribed may increase the risk of side effects due to formoterol

If you use more FORZEROL Zorvicap than you should

Contact your doctor if you use too much.

Possible signs of overdose may include:

  • Tremor
  • Headache
  • Palpitations
  • Fast heartbeat
  • Nausea or vomiting
  • Low potassium
  • High blood sugar
  • Irregular heartbeat

If you forget to use FORZEROL Zorvicap

  • Use it as soon as you remember
  • If it is nearly time for your next dose, skip the missed dose
  • Do not take a double dose

If you stop using FORZEROL Zorvicap

Do not stop treatment suddenly unless your doctor tells you to. Your dose may need to be reduced gradually.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common side effects

  • Palpitations
  • Headache
  • Tremor
  • Mild throat irritation
  • Cough
  • Hoarseness
  • Oral thrush (fungal infection in the mouth)

Uncommon side effects

  • Fast heartbeat (tachycardia)
  • Dizziness
  • Nausea
  • Muscle cramps
  • Anxiety
  • Sleep disturbances
  • Blurred vision

Rare side effects

  • Cardiac arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia, extrasystoles)
  • Bronchospasm
  • Hypokalemia
  • Hyperglycemia
  • Adrenal suppression
  • Growth retardation (in children with prolonged use)
  • Decrease in bone mineral density

Very rare / Frequency not known

  • Severe allergic reactions (anaphylaxis, angioedema, urticaria)
  • Paradoxical bronchospasm
  • Cataract or glaucoma
  • Hypercorticism
  • Depression, behavioural changes (especially in children)
  • Variations in blood pressure
  • Skin bruising

Stop using the medicine and seek medical help immediately if you develop:

  • Sudden worsening of wheezing after inhalation
  • Swelling of face, lips, tongue, or throat
  • Severe rash or allergic reaction
  • Severe chest symptoms or marked palpitations

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to: medico@zorvia.com

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store FORZEROL Zorvicap

  • Store below 30°C
  • Do not freeze
  • Keep out of the sight and reach of children
  • Do not use after the expiry date shown on the pack
  • Store in the original container and protect from moisture

6. Contents of the pack and other information

What FORZEROL Zorvicap contains

Active substances:

  • Formoterol fumarate dihydrate I.P. equivalent to Formoterol Fumarate 6 mcg
  • Budesonide I.P. in strengths of:
    • 100 mcg
    • 200 mcg
    • 400 mcg

Other ingredients:

  • Excipients q.s.
  • Approved colours used in capsule shell

Dosage form

Dry Powder for Inhalation (DPI capsule)

What FORZEROL Zorvicap looks like

Hard capsules containing powder for inhalation through a Dry Powder Inhaler (DPI) device

Pack size

Each FORZEROL Zorvicap is available in a bottle of 30 capsules

Scroll